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Trial record 1 of 1 for:    GRC38
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Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine

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ClinicalTrials.gov Identifier: NCT00561002
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : August 27, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: 2007-2008 Influenza Virus Vaccine
Enrollment 34
Recruitment Details The study participants were enrolled from 29 October 2007 through 27 November 2007 at 1 US site.
Pre-assignment Details A total of 34 participants who met the inclusion and exclusion criteria were enrolled, 2 were not vaccinated and excluded from the analysis.
Arm/Group Title Influenza Vaccine Naive/Inadequately Primed Influenza Vaccine Primed
Hide Arm/Group Description Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14. Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
Period Title: Overall Study
Started 23 9
Completed 23 9
Not Completed 0 0
Arm/Group Title Influenza Vaccine Naive/Inadequately Primed Influenza Vaccine Primed Total
Hide Arm/Group Description Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14. Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 23 9 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 9 participants 32 participants
<=18 years
23
 100.0%
9
 100.0%
32
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Age Continuous Number Analyzed 23 participants 9 participants 32 participants
19.8  (8.76) 24.5  (5.10) 21.2  (8.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 9 participants 32 participants
Female
13
  56.5%
4
  44.4%
17
  53.1%
Male
10
  43.5%
5
  55.6%
15
  46.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 9 participants 32 participants
23 9 32
1.Primary Outcome
Title Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation
Hide Description Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.
Time Frame Days 0-3 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Arm/Group Title Influenza Vaccine Naive/Inadequately Primed Influenza Vaccine Primed
Hide Arm/Group Description:
Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
Overall Number of Participants Analyzed 23 9
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction Post-dose 1 13 4
Any Tenderness 9 2
Grd 3 Tenderness (Cries when limb is moved) 0 0
Any Pain 3 2
Grd 3 Pain (Incapacitating) 0 0
Any Redness (> 0.5 cm) 3 0
Grade 3 Redness (≥ 5.0 cm) 0 0
Any Swelling (> 0.5 cm) 2 0
Grade 3 Swelling (≥ 5.0 cm) 0 0
Any Solicited Injection Site Reaction Post-dose 2 7 0
Any Tenderness 6 0
Grd 3 Tenderness (Cries when limb is moved) 1 0
Any Pain 1 0
Grd 3 Pain (Incapacitating) 0 0
Any Redness (> 0.5 cm) 0 0
Grade 3 Redness) (≥ 5.0 cm) 0 0
Any Swelling (> 0.5 cm) 0 0
Grade 3 Swelling (≥ 5.0 cm) 0 0
Any Solicited Injection Reaction - Any dose 14 4
Any Tenderness 10 2
Grade 3 Tenderness (Cries when limb moved) 1 0
Any Pain 3 2
Grade 3 Pain (Incapacitating) 0 0
Any Redness (> 0.5 cm) 3 0
Grade 3 Redness (≥ 5.0 cm) 0 0
Any Swelling (> 0.5 cm) 2 0
Grade 3 Swelling (≥ 5.0 cm) 0 0
Any Solicited Systemic Reaction Post-dose 1 14 6
Any Fever 4 2
Grade 3 Fever (>103.1 ºF) 1 0
Any Vomiting 1 0
Grade 3 Vomiting (≥ episodes per 24 hr) 0 0
Any Abnormal Crying 9 2
Grade 3 Abnormal Crying (> 3 hr) 0 0
Any Drowsiness 7 3
Grade 3 Drowsiness (Sleeps most of the time) 0 0
Any Loss of Appetite 7 1
Grade 3 Loss of Appetite (Refuses most feeds) 0 0
Any Irritability 11 3
Grade 3 Irritability (Inconsolable) 1 0
Any Headache 0 0
Grade 3 Headache (Prevents daily activities) 0 0
Any Myalgia 2 0
Grade 3 Myalgia (Prevents daily activities) 0 0
Any Malaise 3 3
Grade 3 Malaise (Prevents daily activities) 0 0
Any Solicited Systemic Reaction Post-dose 2 11 0
Any Fever 3 0
Grade 3 Fever (> 103ºF) 0 0
Any Vomiting 0 0
Grade 3 Vomiting (≥ 6 episodes per 24 hr) 0 0
Any Abnormal Crying 5 0
Grade 3 Abnormal Crying (>3 hr) 0 0
Any Drowsiness 5 0
Grade 3 Drowsiness (Sleeps most of time) 0 0
Any Loss of Appetite 3 0
Grade 3 Loss of Appetite (Refuses most feeds) 0 0
Any Irritability 7 0
Grade 3 Irritability (Inconsolable) 0 0
Any Headache 0 0
Grade 3 Headache (Prevents daily activities) 0 0
Any Myalgia 1 0
Grade 3 Myalgia (Prevents daily activities) 0 0
Any Malaise 1 0
Grade 3 Malaise (Prevents daily activities) 0 0
Any Solicited Systemic Reaction (Any dose) 16 6
Any Fever 6 2
Grade 3 Fever (> 103.1 ºF) 1 0
Any Vomiting 1 0
Grade 3 Vomiting (≥ 6 episodes per 24 hr) 0 0
Any Abnormal Crying 10 2
Grade 3 Abnormal Crying (> 3 hr) 0 0
Any Drowsiness 8 3
Grade 3 Drowsiness (Sleeps most of the time) 0 0
Any Loss of Appetite 9 1
Grade 3 Loss of Appetite (Refuses most feeds) 0 0
Any Irritability 12 3
Grade 3 Irritability (Inconsolable) 1 0
Any Headache 0 0
Grade 3 Headache (Prevents activities) 0 0
Any Myalgia 2 0
Grade 3 Myalgia (Prevents activities) 0 0
Any Malaise 3 3
Grade 3 Malaise (Prevents activities) 0 0
2.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination
Hide Description [Not Specified]
Time Frame Day 0 and Day 14 after last dose of Fluzone
Hide Outcome Measure Data
Hide Analysis Population Description
The Geometric Mean Titers analysis were on the per-protocol immunogenicity population.
Arm/Group Title Influenza Vaccine Naive/Inadequately Primed Influenza Vaccine Primed
Hide Arm/Group Description:
Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
Overall Number of Participants Analyzed 16 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Solomon Islands/3/2006 IVR-145 (H1N1) Pre-dose
8.31
(4.48 to 15.4)
5.61
(4.17 to 7.55)
A/Solomon Islands/3/2006 IVR-145 (H1N1) Post-dose
397
(243 to 649)
180
(63.1 to 511)
A/Wisconsin/67/2005 (X-161B) (H3N2) Pre-dose
10.7
(5.11 to 22.5)
59.9
(8.94 to 402)
Wisconsin/67/2005 (X161B) (H3N2) Post-dose
260
(168 to 401)
479
(200 to 1148)
B/Malaysia Split/2506/2004 Pre-dose
12.3
(5.96 to 25.4)
13.3
(3.92 to 45.5)
B/Malaysia Split/2506/2004 Post-dose
186
(72.6 to 477)
180
(70.2 to 459)
3.Other Pre-specified Outcome
Title Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)
Hide Description Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40.
Time Frame Day 14 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The serum hemagglutination inhibition antibody analysis were on the per-protocol immunogenicity population.
Arm/Group Title Influenza Vaccine Naive/Inadequately Primed Influenza Vaccine Primed
Hide Arm/Group Description:
Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
Overall Number of Participants Analyzed 16 6
Measure Type: Number
Unit of Measure: Percentage of Participants
A/Solomon Islands/3/2006 IVR-145 (H1N1) 100 83
A/Wisconsin/67/2005 (X-161B) (H3N2) 100 100
B/Malaysia Split/2506/2004 81 100
4.Other Pre-specified Outcome
Title Seroconversion Rates for Each Influenza Antigen Post-Vaccination
Hide Description Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer < 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0.
Time Frame Day 14 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The seroconversion analysis were on the per-protocol immunogenicity population.
Arm/Group Title Influenza Vaccine Naive/Inadequately Primed Influenza Vaccine Primed
Hide Arm/Group Description:
Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
Overall Number of Participants Analyzed 16 6
Measure Type: Number
Unit of Measure: Percentage of Participants
A/Solomon Islands/3/2006 IVR-145 (H1N1) 100 83
A/Wisconsin/67/2005 (X-161B) (H3N2) 79 67
B/Malaysia Split/2506/2004 80 100
Time Frame Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza Vaccine Primed group) or 42 days post-vaccination (Influenza Vaccine Naïve/Inadequately Primed group)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Influenza Vaccine Naive/Inadequately Primed Influenza Vaccine Primed
Hide Arm/Group Description Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14. Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
All-Cause Mortality
Influenza Vaccine Naive/Inadequately Primed Influenza Vaccine Primed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Influenza Vaccine Naive/Inadequately Primed Influenza Vaccine Primed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Influenza Vaccine Naive/Inadequately Primed Influenza Vaccine Primed
Affected / at Risk (%) Affected / at Risk (%)
Total   12/23 (52.17%)   3/9 (33.33%) 
General disorders     
Injection site tenderness  1  10/23 (43.48%)  2/9 (22.22%) 
Injection site pain  1  3/23 (13.04%)  2/9 (22.22%) 
Injection site redness  1  3/23 (13.04%)  0/9 (0.00%) 
Injection site swelling  1  2/23 (8.70%)  0/9 (0.00%) 
Pyrexia  1  6/23 (26.09%)  2/9 (22.22%) 
Malaise  1  3/23 (13.04%)  3/9 (33.33%) 
Metabolism and nutrition disorders     
Anorexia  1  9/23 (39.13%)  1/9 (11.11%) 
Nervous system disorders     
Somnolence  1  8/23 (34.78%)  3/9 (33.33%) 
Psychiatric disorders     
Crying  1  10/23 (43.48%)  2/9 (22.22%) 
Irritability  1  12/23 (52.17%)  3/9 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00561002     History of Changes
Other Study ID Numbers: GRC38
First Submitted: November 19, 2007
First Posted: November 20, 2007
Results First Submitted: July 20, 2009
Results First Posted: August 27, 2009
Last Update Posted: April 14, 2016